700 Participants Needed

Sociocultural Influences on Pain Assessment

AO
LY
Overseen ByLauren Y Atlas, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: National Center for Complementary and Integrative Health (NCCIH)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Objective The current proposal investigates behavioral, psychophysiological, and social processes that may help explain biases and disparate outcomes in pain. Health disparities, or health outcomes that adversely affect disadvantaged populations, are pervasive and apparent in many diseases and symptoms, including pain. Pain is the number one reason individuals seek medical treatment. Health disparities in pain encompass both differences in pain experience and treatment for pain. For instance, research indicates that Black individuals report increased pain and have reduced pain tolerance relative to White individuals, yet doctors are less likely to treat minority patients pain and underestimate their pain experience. This project aims to address this systemic discrepancy by focusing on interpersonal processes that may contribute to these disparities, including socially-relevant responses to pain (i.e. pain expression) and pain assessment (e.g. visual attention). The proposed research aims to determine whether the study of pain expressions and their assessment can yield insights on how social factors shape pain and its treatment. Further, we test the efficacy of potential interventions designed to improve accuracy and reduce biases in pain assessment. If successful, this work will form the foundation of a new research program that will link the field of pain research with the field of social neuroscience, and forge new insights on the critical problem of health disparities in pain. Study population We will accrue up to 700 total healthy volunteers to target 262 completers Design Our overall aim is to understand how social factors influence the assessment and management of pain, and to gain insight into psychosocial processes that may underlie health disparities in pain. We propose a series of studies designed to test these links. First, we will measure pain perception and physiological responses to painful stimuli in a diverse group of individuals to test for sociocultural and biological influences on pain and pain-related responses. In subsequent studies, new participants ("perceivers") will view images of these initial participants ("targets") and will provide estimates of 'targets' pain experience. We will measure a) whether perceivers can accurately estimate 'targets' pain experience; b) whether accuracy differs as a function of similarity between target and perceiver (ingroup vs outgroup); and c) whether individuals can improve accuracy through feedback. Outcome measures Primary outcome measures for all experiments will be decisions about pain (experienced by self or other) measured with visual analogue scales, reaction time, and/or categorical judgments (pain/no pain). We will also measure physiological responses (e.g., facial muscle response, skin conductance, pupil dilation) and brain responses using functional magnetic resonance imaging (fMRI) as secondary outcome measures. We will test whether pain and pain-related responses varies as a function of sociocultural/demographic factors (e.g. race, ethnicity, sex) and whether accuracy in assessing others pain is influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g. performance-related feedback)....

Do I need to stop taking my current medications for this trial?

Yes, if you regularly use prescription medications that significantly affect pain or heat perception, such as opiates, antidepressants, anticonvulsants, anxiolytics, hypnotics, antipsychotics, antimigraine agents, and muscle relaxants, you will need to stop taking them. However, using non-prescription pain relievers like ibuprofen or acetaminophen occasionally is allowed, as long as the last dose was not taken within 5 half-lives of testing.

What data supports the effectiveness of this treatment for pain assessment?

Research shows that alternating heat and cold therapy can improve muscle stiffness and subjective symptoms, while electrical stimulation is effective for controlling acute pain in many patients. These components suggest potential benefits for pain assessment and management.12345

Is the treatment generally safe for humans?

The treatments mentioned, such as electrical stimulation and thermal stimulation, have been used safely in humans for pain management and research. Safety features are often included to prevent harm, like avoiding burns during thermal stimulation, and electrical stimulation is a well-accepted method for controlling pain.34678

How does the treatment in the trial differ from other pain treatments?

This treatment is unique because it combines cold water immersion, electric shock stimulation, and thermal stimulation to assess pain, which is different from standard pain treatments that often rely on medications or single-method therapies. The use of these physical stimuli allows researchers to explore how different cultural backgrounds might influence pain perception and response.13479

Research Team

LY

Lauren Y Atlas, Ph.D.

Principal Investigator

National Center for Complementary and Integrative Health (NCCIH)

Eligibility Criteria

Healthy adults aged 18-60 who speak English fluently and can consent to participate are eligible for this study. Excluded are those with chronic pain conditions, certain medical issues affecting sensation or pain perception, employees of NCCIH and NIMH, non-US residents, and individuals taking specific prescription medications.

Inclusion Criteria

All Sub-Studies: Healthy
I am between 18 and 60 years old.
All Sub-Studies: Able to provide written informed consent
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Exclusion Criteria

I have scars, burns, or a recent tattoo in the test area that could affect skin sensitivity.
I don't regularly use meds that affect pain or heat feeling, except for occasional painkillers.
All Sub-Studies: Has a major-medical condition or medical history that in a clinician's assessment could affect ability to comply with study procedures, including neurological or psychiatric conditions (including stroke and blindness or deafness, a history of brain damage, substance or alcohol dependence or abuse or psychosis)
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Measure pain perception and physiological responses to painful stimuli in a diverse group of individuals

4-6 weeks
Multiple visits (in-person)

Perception Study

New participants view images of initial participants and provide estimates of their pain experience

4-6 weeks
Multiple visits (in-person)

Feedback and Training

Participants receive feedback on their performance to improve accuracy in pain assessment

4-6 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for accuracy and biases in pain assessment after interventions

4 weeks

Treatment Details

Interventions

  • Cold water bath
  • Electric shock stimulator
  • Medoc thermal stimulator
  • Pain assessment performance feedback
Trial OverviewThe trial investigates how social and cultural factors influence the experience of pain and its assessment by others. It involves electric shocks, thermal stimulation via a thermode device, cold water immersion tests, facial expression recording during painful stimuli, heart activity monitoring, sweat measurement sensors on the hand, facial muscle electrical activity testing through electrodes attached to the skin.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Substudy 3: Feedback GroupExperimental Treatment1 Intervention
Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
Group II: Substudy 1: All participantsExperimental Treatment3 Interventions
Measuring facial response to painful stimulation.
Group III: Substudy 2: Healthy volunteersActive Control1 Intervention
Measuring pain assessment accuracy
Group IV: Substudy 3: ControlActive Control1 Intervention
Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Center for Complementary and Integrative Health (NCCIH)

Lead Sponsor

Trials
886
Recruited
677,000+

Findings from Research

External electrical stimulation effectively controls acute pain in approximately 80% of patients, making it a promising option for immediate pain relief.
For chronic pain, however, only about 25% of patients experience significant relief from this method, suggesting the need for a more comprehensive treatment approach that includes therapies like operant conditioning and physical exercise.
The viability of external electrical stimulation as a therapeutic modality.Shealy, CN.[2011]
Superficial heating and cooling techniques have been shown to effectively relieve low to moderate pain in children, similar to their use in adults, but standardized guidelines were lacking in UK children's centers before this project.
After three years of implementing new protocols and educational support for these pain relief methods, an audit confirmed their benefits, highlighting their role in providing cost-effective and holistic care for pediatric patients.
Managing pain using heat and cold therapy.Lane, E., Latham, T.[2019]
Transcutaneous electrical stimulation is a widely accepted method for managing various types of pain, including chronic and acute pain, demonstrating its efficacy as a therapeutic option.
Implantable peripheral nerve stimulators have shown the highest effectiveness for treating pain related to peripheral nerve injuries, although their effectiveness for pain outside the stimulated nerve's distribution remains unproven.
Electrical stimulation for the control of pain.Long, DM.[2019]

References

The viability of external electrical stimulation as a therapeutic modality. [2011]
Managing pain using heat and cold therapy. [2019]
Electrical stimulation for the control of pain. [2019]
TNS-evoked long loop effects. [2019]
Effects of alternating heat and cold stimulation at different cooling rates using a wearable thermo device on shoulder muscle stiffness: a cross-over study. [2022]
A contact thermal stimulator for neurobehavioral research on temperature sensation. [2019]
Lasers and other thermal stimulators for activation of skin nociceptors in humans. [2019]
Neuromuscular electrostimulation techniques: historical aspects and current possibilities in treatment of pain and muscle waisting. [2022]
Thermosensitivity of muscle: high-intensity thermal stimulation of muscle tissue induces muscle pain in humans. [2022]